1. Field of the Invention
This invention relates to medical devices. Specifically, the present invention relates to an oral airway for maintaining a patent airway for spontaneously ventilating patients undergoing sedation for surgical, endoscopic, bronchoscopic, and fiber optic intubation procedures.
2. Description of the Related Art
Each year in the United States, more than twenty million surgeries are performed on an outpatient basis. With these surgeries, as well as those performed in office-based surgical practices, regional/local anesthesia and intravenous sedation are growing in popularity as the preferred sedation method. Nurses having little or no specialized anesthesia training are administering intravenous sedation for a growing number of procedures. Compared to general anesthesia, patients can recover more quickly and experience less postoperative pain and nausea and vomiting, while experiencing greater satisfaction and more rapid discharge to their homes.
Airway emergencies are the most common complication during moderate and deep procedural sedation. One of the earliest indications of airway compromise is a change in end tidal carbon dioxide (ETCO2). Currently, there are several options to manage the airway of sedated patients: oral endotracheal tubes (OETT); the laryngeal mask airway (LMA); and the cuffed oral pharyngeal airway (COPA). All of these options require advanced training and connection of the device to some external form of supplemental oxygen or an anesthesia circuit, and are not available to the non-anesthesia trained nurse.
As discussed in co-pending U.S. patent application Ser. No. 11/838,975, a nasal oxygen cannula is typically used to supplement oxygen in patients under sedation who are able to maintain an unobstructed airway, and is frequently accompanied by ETCO2 monitoring. The nasal oxygen cannula is not, however, capable of assisting the patient in maintaining a clear airway. Since patients under sedation often experience relaxed oral or pharyngeal tissues which may interfere with breathing, additional mechanical assistance may be required to maintain a patent airway in these circumstances. Additionally, sedated patients undergoing procedures through the mouth, such as endoscopy and bronchoscopy, frequently experience airway obstruction. Although OETT, LMA and COPA provide this mechanical assistance, they are poorly tolerated by patients unless deep sedation or general anesthesia is administered.
Although there are no known prior art teachings of a solution to the aforementioned deficiency and shortcoming such as that disclosed herein, prior art references that discuss subject matter that bears some relation to matters discussed herein are U.S. Pat. No. 7,278,420 to Ganesh et al. (Ganesh), U.S. Pat. No. 4,683,879 to Williams (Williams), and U.S. Pat. No. 6,098,617 to Connell (Connell).
Ganesh discloses an oropharyngeal device for insertion into the mouth of a patient. The device includes a distal end and proximal end having a flange formed at the proximal end. The body is sized such that the distal end of the body is disposed within the pharynx above the epiglottis. The device includes at least three separate conduits integrated into the body for administering oxygen, suctioning and for assessing ventilation through end-tidal carbon dioxide monitoring. However, Ganesh does not disclose a device for use in maintaining an airway during endoscopic or intubating procedures. Furthermore, Ganesh suffers from the disadvantage of placing the end-tidal carbon dioxide monitoring conduit near the proximal end of the device, which is not the most advantageous position to obtain accurate readings from the patient.
Williams discloses a dual function connector for releasable attachment to an endopharyngeal tube or airway intubator. However, Williams does not teach or suggest a device for maintaining an airway, providing oxygen supplementation, or ETCO2 monitoring for a patient.
Connell discloses a device adapted for use with a conventional oral or nasopharyngeal airway for delivering an inhalant gas to a proximal end of the airway and for sampling exhalent gas at a distal end of the airway. However, Connell does not teach or suggest a device for use in maintaining an airway during an endoscopic or intubating procedure.
It would be an advantage to have a device which maintains a patent airway, provides for oxygen supplementation and ETCO2 monitoring in spontaneously ventilating, sedated patients as well as allows the placement and use of scopes in various medical procedures. Furthermore, a device is needed which enables the airway device to be used by non-anesthesia trained medical providers. It is an object of the present invention to provide such an apparatus.